To Evaluate the Pharmacokinetics of IDX719 in Subjects With Normal and Impaired Hepatic Function
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/3/2014 |
| Start Date: | August 2013 |
| End Date: | March 2014 |
| Contact: | John Z Sullivan-Bolyai, MD |
| Email: | clinicaltrials@idenix.com |
| Phone: | 877-433-6491 |
A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of IDX719 in Subjects With Normal and Impaired Hepatic Function
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and
tolerability of single-dose administration of IDX719 in subjects with normal hepatic
function and subjects with varying degrees of hepatic impairment.
tolerability of single-dose administration of IDX719 in subjects with normal hepatic
function and subjects with varying degrees of hepatic impairment.
Inclusion Criteria:
- Read and sign the written informed consent form (ICF) after the nature of the study
has been fully explained.
- All subjects of childbearing potential must have agreed to use a double method of
birth control (one of which must be a barrier) from Screening through at least 90
days after the last dose of the study drug.
- Male subjects have agreed not to donate sperm from Day -1 through 90 days after the
last dose of study drug.
Exclusion Criteria:
- Pregnant or breastfeeding.
- Other clinically significant medical conditions or laboratory abnormalities
We found this trial at
2
sites
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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